Arista Latindo Industrial Ltd. P.T

Arista Latindo Industrial Ltd. P.T specializes in single-use examination gloves, offering a range of materials and formulations. Their portfolio includes vinyl gloves (pre-powdered, powder-free, and with added vitamin E), latex gloves (powder-free, polymer-coated, and low-protein variants), and nitrile gloves (powder-free in colors like purple). These gloves are non-sterile and designed for medical, dental, or laboratory use.

The company is headquartered in the United States. This location is relevant for regulatory compliance and distribution, particularly for devices marketed in North America.

The company’s examination gloves are listed in the FDA’s 510(k) registry. This registry tracks Class I devices that have been determined to be substantially equivalent to a predicate device, ensuring they meet U.S. regulatory requirements for safety and performance.

All of Arista Latindo Industrial Ltd. P.T’s examination gloves fall under Class I device classification. This classification applies to low-risk devices like single-use gloves, which are generally considered safe and effective for their intended purpose without requiring stringent pre-market approval beyond basic compliance.

The FDA’s 510(k) registry includes devices that have been cleared through the 510(k) premarket notification process, demonstrating they are substantially equivalent to a legally marketed predicate device. For Class I gloves, this means the manufacturer has shown their product meets FDA requirements for materials, labeling, and manufacturing practices without requiring clinical trials or extensive testing, as these devices pose minimal risk.